Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503490
Status:
COMPLETED
Last Update Posted:
2018-01-19
First Post:
2007-07-16
Brief Title:
Safety Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis
Sponsor:
Horizon Pharma USA Inc
Organization:
Horizon Pharma USA Inc
Study Overview
Official Title:
Phase I Single and Multi-dose Placebo Controlled Randomized Dose-Escalation Study to Evaluate the Safety Tolerability and PK Profile of MP-376 Using the PARI eFlow Nebulizer for 14 Days to CF Patients
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with cystic fibrosis CF suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria including Pseudomonas aeruginosa which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms and reduce the emergence of resistant bacteria
Detailed Description:
This trial will be a single-blind placebo-controlled dose escalating between cohorts single and multi-dose multi-center study to evaluate the safety tolerability and pharmacokinetic profile of levofloxacin administered as MP-376 once then twice daily for 14 days by the aerosol route to CF patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None